A previous phase 2 study demonstrated that induction chemotherapy followed by chemoradiotherapy and surgery is efficacious in patients with stage 3A(N2) disease and certain patients with stage 3B NSCLC.

For the phase 3 study, researchers enrolled 246 patients with pathologically proven 3A(N2) and selected patients with 3B disease that were eligible for further treatment after receiving induction chemotherapy consisting of cisplatin and paclitaxel, as well as concurrent chemoradiotherapy with cisplatin and vinorelbine.

After induction, 161 patients with resectable tumors were randomly assigned to receive a chemoradiotherapy boost or to undergo surgery.

Overall survival rates were 44% in the surgery arm and 40% in the chemoradiotherapy boost arm, and progression-free survival rates were 32% and 35%, respectively. Of the 246 patients enrolled, 34.1% were still alive at 5 years.